When Was Sublocade FDA-Approved for Opioid Use Disorder?

Sublocade, a long-acting, injectable form of the drug buprenorphine, was approved by the FDA in 2017. In 2025, the FDA approved an important label change for Sublocade that minimized the initiation period required for the drug and allowed for additional injection site options.

Before starting Sublocade, it is essential to learn as much as possible about this relatively new medication. The medication can be a powerful treatment for opioid use disorder, but it is not without risks or serious side effects. There could be other disadvantages to taking Sublocade, and this drug is not intended for everyone.

Key Points

• Sublocade was FDA-approved for use in the medication-assisted treatment of opioid use disorder in 2017.
• Sublocade is the long-acting version of the generic drug buprenorphine.
• FDA approval was granted for Sublocade after many successful clinical trials proving its effectiveness and safety.
• The FDA approved label changes for Sublocade in 2025 that allowed for a more rapid initiation period as well as alternatives for injection sites.
• Talk to your doctor about common and serious side effects associated with Sublocade and other drugs that contain buprenorphine.
• Tell your doctor about any medical conditions you have, as well as any medications (or other substances) you’re taking, before beginning a regimen of Sublocade.
• Consider all of your options for the treatment of opioid addiction before beginning Sublocade or any other medication.

What Is Sublocade?

Sublocade is the brand name for a subcutaneous, extended-release version of the drug buprenorphine. While some forms of buprenorphine are prescribed for pain relief, Sublocade is FDA-approved for the treatment of opioid use disorder (OUD).

Sublocade is a type of opioid itself and is considered a Schedule III controlled substance.[1] It is only available by prescription. Sublocade is subject to a Risk Evaluation and Mitigation Strategy (REMS) program, but this does not require enrollment in a rehabilitation program; rather, it ensures providers and pharmacies comply with specific safety protocols.

The recommended Sublocade dosing regimen begins with 300 mg once monthly for the first two months, followed by 100 mg once monthly as maintenance. However, some patients may continue on 300 mg if clinically indicated. [2]

Sublocade is not intended for self-administration. Injectable doses are designed for administration only by licensed healthcare providers in approved healthcare settings. Sublocade is typically just one part of a comprehensive treatment plan for opioid use disorder that also includes intensive substance use and rehabilitation counseling.

When Was Sublocade FDA Approved?

Sublocade is still a relatively new drug. After being fast-tracked for approval in 2016, Sublocade was officially approved for opioid use disorder treatment by the U.S. Food and Drug Administration on November 30, 2017. [3] The FDA approval came with some strings attached. Sublocade is approved by the FDA for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product. Moreover, this extended-release form of buprenorphine is only FDA-approved for patients who have previously taken the transmucosal form of buprenorphine before starting Sublocade treatment.

Sublocade: Key Clinical Trials and Subsequent Studies

For any drug in the United States to receive FDA approval, it must go through a rigorous application process. This process often involves several clinical trials and other studies designed to assess its effectiveness and safety in patients.

Indivior, the maker of Sublocade, performed clinical trials before FDA approval to test the effectiveness of a buprenorphine extended-release injection. Clinical data indicated that buprenorphine plasma concentrations ≥2 ng/mL were associated with significantly reduced illicit opioid use, with improved outcomes seen in patients achieving that threshold.  [4]

A subsequent 12-week Opioid Blockade Study demonstrated the capability of 300 milligrams of Sublocade to entirely block the “drug-liking effects” of a powerful opioid pain medication at both low doses and higher doses. [5]

A Phase 3 pivotal study of Sublocade evaluated the effects of various dosage regimens of the drug compared to a placebo group. Results showed that all dosing protocols were superior to the placebo. [6]

Sublocade Label Changes

In February 2025, the FDA approved label changes for Sublocade following the successful completion of studies conducted by Indivior. These label changes included: [7]

• Approval for a more rapid initiation of Sublocade, meaning patients can begin receiving the drug after just a single dose of transmucosal buprenorphine
• Expanded options for injection, including more approved injection sites (e.g., arm, stomach, buttocks, and thighs).

How Is Sublocade Used?

Using a prefilled syringe, Sublocade is delivered via an injectable liquid dose by a healthcare professional. Before receiving Sublocade, the patient must have already received an initial dose of buprenorphine. [8] A trained health care professional will inject a dose of Sublocade at the injection site, which is typically the upper arm, abdomen, thighs, or buttocks.

Once administered, the liquid dose of Sublocade becomes solidified into a “depot.” It will be noticeable by touch, but the patient is advised not to try to remove it. The patient should also avoid massaging or rubbing the depot or wearing tight clothing around the injection site. [9]

Sublocade Side Effects

Upon beginning Sublocade treatment for OUD, a doctor will typically review the medication guide with the patient, which includes an overview of potential side effects. Some of the more common Sublocade side effects listed include: [10]

• Fatigue
• Nausea
• Vomiting
• Constipation
• Pain during urination
• Headache
• Insomnia
• Abnormal liver functioning
• Injection site reactions, like pain or burning

Other, more serious side effects of Sublocade can occur, and some can be life-threatening.

Who Should Avoid Sublocade?

It’s important to tell your doctor about any medical conditions you have or have had in the past, as well as any medications you’re currently taking.

Some people with the conditions listed below may need to avoid Sublocade and ask about alternative treatment options for opioid use disorder: [11]

• Head injury
• Brain conditions
• Breathing problems
• Sleep apnea
• Liver disease
• Kidney disease
• Problems urinating
• Mental health conditions
• Alcoholism
• Gallbladder issues
• Thyroid problems
• Latex allergy
• Enlarged prostate
• Adrenal gland problems
• Electrolyte imbalance
• Heart disease

Some medications may affect how Sublocade works or result in a dangerous drug interaction. Before taking Sublocade, tell your doctor if you’re taking any of the following drugs: [12]

• Other opioid medications
• Sedative benzodiazepines (e.g., Xanax, Valium)
• Antidepressants
• Stimulant drugs
• Migraine medications
• Sleep medicines
• Muscle relaxers
• Asthma medications
• Heart medications
• Medications for an overactive bladder
• Allergy medications
• Medications for Parkinson’s disease
• Medications for motion sickness

It’s always a good idea to tell your doctor about any other substances you’re taking before beginning a new drug regimen. This includes any prescription medications, over-the-counter medications, illicit drugs, vitamins, and herbal supplements.

Is Sublocade A Viable Treatment Option for OUD?

Sublocade represents one of the treatment options for opioid dependence, but there are others. Only a healthcare provider who has assessed your symptoms and overall health can tell you whether Sublocade is a viable option for you. Either way, if you think you or a loved one has an opioid addiction or is experiencing opioid withdrawal symptoms, it’s imperative to seek professional assistance.